Long-term results of valvular replacement with the Carbomedics prosthesis.

The Carbomedics valve prosthesis is a second generation mechanical prosthes is with a double hemi-disc. This study analysed long-term morbidity and mor tality associated with this prosthesis. Between 1987 and 1996, 397 prostheses were implanted, 306 aortic, 42 mitral and 26 double replacements (3 combining a Carbomedics aortic prothesis wit h a mitral valve from another type) in 370 patients with a mean age of 62 ( range 4 to 88 years). The global operative mortality was 7.4%. A questionna ire sent to treating cardiologists, general practitioners and patients upda ted the prospective data base of the cardiac surgical department. The follo w-up was 99%, representing a total of 1244 patient-years with an average of 41 months (range 1.1 month to 9.9 years). The 1, 3, 3 and 7 year survival (operative mortality included) was 88%, 80% , 76% and 69.6% respectively. Haemorrhagic complications were the most comm on (17 cases, 1.36% per patient-year) and 1 1 thromboembolic episodes were observed (0.88% per patient-year) with a higher incidence (pi 10-4) in mitr al valve replacement (3.8% in patient-year). The other complications observ ed were : 3 aseptic paravalvular leaks (0.4% per patient-year) and 5 prosth etic valve infections; no structural alterations were observed In all, ten reoperations (0.8% per patient-year) were required for prosthetic valve com plications. This study shows the reliability of Carbomedics valve prostheses with a low complication rate comparable to that of other modern mechanical valve pros theses.